CTTQ
Status and phase
Conditions
Treatments
About
This study is a multicenter, single-group, open-label study to evaluate the safety and tolerability of TQH2929 injection at a dose of 900mg in adult subjects with active Generalized Pustular Psoriasis (GPP), and to preliminarily evaluate the efficacy.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Patients with primary plaque psoriasis vulgaris with pustules that are restricted to psoriatic plaques;
Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator;
Computed Tomography of the chest shows active or occult tuberculosis or a history of contact with an open tuberculosis (TB) subject within the past 6 months. Subjects positive for tuber closes spot(T-SPOT) (or other tuberculosis diagnostic test) result;
Active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg);
History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening during screening;
Positive antibodies to treponema pallidum during screening;
History of serious infection leading to hospitalization or intravenous infusion of antibiotics or antiviral therapy within 3 months prior to baseline;
Active systemic infections requiring systemic antibiotics or systemic antiviral therapy within 4 weeks prior to baseline;
History of opportunistic infection and parasitic infection within 6 months prior to the screening period;
History of herpes zoster infection within 2 months prior to baseline;
Subject has known or suspected autoimmune disease;
Receive major surgery within 4 weeks prior to the first dose;
Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period;
Subjects have history of significant drug allergies;
Use of the following medications within the prescribed time:
People who are alcoholic, drug addicts, and known drug dependents;
Pregnant or Breasting feeding subject;
Received a blood transfusion within 4 weeks prior to the first dose;
Subject is unable to tolerate intravenous infusion administration;
During the period of participation in this study, participants had planned surgical procedures;
Have participated in clinical trials of other drugs or medical devices within 4 weeks prior to baseline;
In the judgment of the investigator or sponsoring medical auditor, it is believed that there are any medical or psychiatric symptoms that put the subject at risk, interfere with participation in the study, or interfere with the interpretation of the results of the study.
Primary purpose
Allocation
Interventional model
Masking
10 participants in 1 patient group
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Central trial contact
Hang Li, Doctor; Xia Zhao, Master
Data sourced from clinicaltrials.gov
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